FDA open to use of new MRD end­point ahead of ad­vi­so­ry com­mit­tee meet­ing

The FDA seems open to a new end­point that could ac­cel­er­ate the de­vel­op­ment of new treat­ments for mul­ti­ple myelo­ma.

The agency’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee will meet on Fri­day to dis­cuss the use of min­i­mal resid­ual dis­ease (MRD) — a mea­sure of can­cer cells re­main­ing in a pa­tient’s bone mar­row — as a sur­ro­gate end­point to sup­port ac­cel­er­at­ed ap­provals in mul­ti­ple myelo­ma.

De­pend­ing on the set­ting, es­tab­lish­ing the new end­point could shave years off the drug de­vel­op­ment process, Fred Hutch Can­cer Cen­ter as­sis­tant pro­fes­sor Rahul Baner­jee told End­points News. 

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